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Phase III Adjuvant Chemotherapy with Urokinase or Urokinase/Warfarin for Resectable Dukes B/C Adenocarcinoma of the Colon and Rectum

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Treatment

Closed

under 70

EORTC-19793
UKM-HH-1

Objectives

I.  Evaluate the efficacy of fibrinolytic therapy with urokinase with or 
without oral anticoagulation therapy with warfarin as adjuvant treatment for 
resectable colorectal cancer.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients under 70 years old with 
Dukes Stage B and C colorectal adenocarcinoma.  Patients must be medically 
eligible for anticoagulant therapy and must not have had long term prior 
anticoagulant treatment.

Expected Enrollment

525 patients will be entered.

Outline

Randomized study.  Patients are randomized following Surgery.
Regimen A:  Surgery.  Resection of tumor.
Arm I:  No therapy.
Arm II:  Single-agent Chemotherapy.  Urokinase, UK.
Arm III:  2-Drug Combination Chemotherapy.  UK; Warfarin, NSC-59813.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Maurice J. Staquet, MD, Protocol chair
Ph: 32-2-541-3501

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.